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Review
. 2020 Mar 3;13(3):38.
doi: 10.3390/ph13030038.

[68Ga]Ga-DOTA-TOC: The First FDA-Approved 68Ga-Radiopharmaceutical for PET Imaging

Ute Hennrich  1 , Martina Benešová  2
Affiliations
Review

[68Ga]Ga-DOTA-TOC: The First FDA-Approved 68Ga-Radiopharmaceutical for PET Imaging

Ute Hennrich et al. Pharmaceuticals (Basel). .

Abstract

In the United States, [68Ga]Ga-DOTA-TOC has been approved by the Food and Drug Administration (FDA) in 2019 as the first 68Ga-radiopharmaceutical for imaging of somatostatin receptor (SSTR) positive gastroenteropancreatic neuroendocrine tumors while employing positron emission tomography (PET). In Europe (Austria, Germany, France), [68Ga]Ga-DOTA-TOC was already approved back in 2016. This radiopharmaceutical combines the radionuclide 68Ga with the somatostatin analogue DOTA-TOC for specific imaging of tumor cells expressing SSTRs. Such a targeting approach can also be used for therapy planning in the case of both localized as well as disseminated disease and potentially for the evaluation of treatment response.

Keywords: [68Ga]Ga-DOTA-TOC; neuroendocrine tumors (NETs); positron emission tomography (PET); somatostatin receptor (SSTR); theranostics.

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Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Principle of positron emission tomography (PET). β+: positron, e−: electron from surrounding tissue.
Figure 2
Figure 2
DOTA-TOC timeline. The first use for in-human imaging with [68Ga]Ga-DOTA-TOC and its FDA approval are highlighted in blue.
Figure 3
Figure 3
Structure of [68Ga]Ga-DOTA-TOC.
See this image and copyright information in PMC

References

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    1. FDA Letter of Approval for NETSPOTTM. [(accessed on 28 October 2019)]; Available online: https://www.accessdata.fda.gov/ drugsatfda_docs/appletter/2016/208547Ori....

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